berlinger SmartMonitor SITE L User manual

User Manual
SmartMonitor
1 — Last update: 31 October 2022
Berlinger & Co. AG
Copyright © 2022 Berlinger & Co. AG

Table of Contents
1. Home .................................................................................................................................................. 2
2. Device application information......................................................................................................... 3
2.1. Intended use .............................................................................................................................. 4
2.2. Device handling warnings .......................................................................................................... 7
2.3. Device use ............................................................................................................................... 10
2.4. Device cleaning........................................................................................................................ 11
2.5. Battery information & use ......................................................................................................... 12
2.6. Device lifetime.......................................................................................................................... 15
2.7. Air freight ................................................................................................................................. 16
2.8. Communication & Geographical Positioning ............................................................................. 17
2.8.1. Communication ................................................................................................................ 18
2.8.2. Geographical Positioning ................................................................................................. 19
3. Device & display information.......................................................................................................... 20
3.1. Device...................................................................................................................................... 21
3.2. Display..................................................................................................................................... 24
3.3. Acoustic alarm (SmartMonitor SITE L only) .............................................................................. 25
4. Device configuration ....................................................................................................................... 26
4.1. WiFi Setup for SmartMonitor (SITE L only)............................................................................... 28
5. How to configure your device......................................................................................................... 30
6. How to charge your device ............................................................................................................. 35
6.1. Charging before use (SmartMonitor SHIP L and SITE L) .......................................................... 36
6.2. Permanent charging (SmartMonitor SITE L only)...................................................................... 37
7. How to place your device with external sensor ............................................................................. 38
7.1. Site .......................................................................................................................................... 39
7.2. Shipment.................................................................................................................................. 41
8. How to place your device without external sensor........................................................................ 43
8.1. Site .......................................................................................................................................... 44
8.2. Shipment.................................................................................................................................. 45
9. Device info before device start ....................................................................................................... 46
10. How to start your device ............................................................................................................... 47
11. Running device.............................................................................................................................. 49
11.1. Device info when device is running......................................................................................... 50
11.2. Device alarm while running .................................................................................................... 53
11.3. Cloud sync while running........................................................................................................ 54
12. How to stop your device ............................................................................................................... 55
13. Prepare SmartMonitor for re-use ................................................................................................. 60

14. Additional functionalities .............................................................................................................. 62
14.1. Manual flight mode ................................................................................................................. 63
15. Warning.......................................................................................................................................... 65
15.1. Display warnings .................................................................................................................... 66
16. Disposal ......................................................................................................................................... 69
17. Certification & Standards.............................................................................................................. 70
18. FAQ & Glossary ............................................................................................................................. 72

1. Home
Reference number: MKT-80025-EN
Valid from 11/2022
Quick Setup – Monitoring for Shipment and Site
Use this flow to operate your device:
Configure your device
Place your device
– with external SmartSensor
– without external sensor
Start your device
Stop your device
Prepare your device for re-use
Contact Berlinger Support for help.
The information is applicable for SmartMonitor SITE L, SHIP L and SHIP M.
!
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2. Device application information
•Intended use
•Device handling warnings
•Device use
•Device cleaning
•Battery information & use
•Device lifetime
•Air freight
•Communication & Geographical Positioning
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2.1. Intended use
The SmartMonitor is designed for the monitoring of temperature sensitive pharmaceutical goods in
storage and/or transport. The device collects and automatically uploads data to the compatible cloud
solution SmartView, for immediate decision-making on product integrity.
Available device models:
SmartMonitor SHIP L
Modular real-time monitoring for shipments.
• Fully featured: in addition to temperature, providing condition data on humidity and operational
handling (e.g., light, shock) for quality assurance and security purposes.
• Reusable: enabling reuse and refurbishment on established trade lanes, where device return, and
reuse is feasible.
• The SmartMonitor is capable to supervise product and environment temperature simultaneously,
enabled by the optional SmartSensor.
SmartMonitor SHIP M
Modular real-time device for shipments. Slim featured and single use.
• Slim featured: Real-time temperature & humidity monitoring.
The information is applicable for SmartMonitor SITE L, SHIP L and SHIP M. For detailed
information, read the technical specifications.
*
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• Single use: single use devices for challenging destinations, where device return and reuse is not
feasible.
• The SmartMonitor is capable to supervise product and environment temperature simultaneously,
enabled by the optional SmartSensor.
SmartMonitor SITE L
Modular real-time monitoring for the monitoring of refrigerator/freezers. Fully featured and reusable.
Permanent charging required.
• Fully featured: in addition to temperature, providing condition data on humidity and operational
handling (e.g., light, shock) for quality assurance and security purposes
• Additional data synchronization possibilities through WiFi.
• The SmartMonitor is capable to monitor product and environment temperature simultaneously,
enabled by the optional SmartSensor.
Available sensor models:
SmartSensor
Berlinger offers a range of external sensors with the SmartMonitor, which can be easily and securely
applied to the SmartMonitor via the sensor socket (M5), after removing the sensor cap.
SmartSensor TEMP
The SmartSensor monitors products that are being transported or stored in refrigerators/freezers at
temperatures from -40 to +75°C.
SmartSensor GLYCOL
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SmartSensor Glycol for the monitoring of products in transport or storage in refrigerators/freezers at
temperatures from -40 to +60°C. The glycol bottle simulates the temperature exposure behavior of vials.
It is ideal to reduce sudden temperature fluctuations, like refrigerator door/packaging opening or
defrosting cycles, while it accurately captures the temperature exposure of the vials monitored.
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2.2. Device handling warnings
Air Pressure • Excess pressure or vacuum can damage the device.
Attention
• The SmartMonitor measures the ambient temperature and not the quality of the
monitored goods. Its purpose is to signal if product quality evaluation is
required.
Automatic
flight mode
• Automatic flight mode may not be activated in all aircraft types. Enable manual
flight mode in case of doubt and/or regulation prescribes that radio must be
suspended.
Battery
• The battery cannot be removed or replaced. Check the technical specification
for detailed battery information. Contact the Berlinger support at
[email protected] for refurbishment options.
• Risk of fire or explosion if the battery is replaced by an incorrect type.
• Risk of explosion if the battery is disposed of in a fire or hot oven.
• Leaving the battery in an extremely high temperature surrounding environment
can result in an explosion or leakage.
• Do not subject battery to extremely low air pressure that may result in an
explosion or the leakage of flammable liquid or gas.
• Instructions required by IEC 62368-1 regarding coin cells.
Compatibility • SmartMonitor device only works in combination with the SmartView software
(version 6.0 or higher).
Connectivity • Real-time availability of measurements may depend on local connectivity and
may be delayed.
Damage • If the SmartMonitor device is damaged, don’t use it and contact Berlinger
support for refurbishment options.
General
• Ensure that the user manual instructions are followed before using the
SmartMonitor for monitoring. Without proper starting, the measurements will not
be available.
Humidity and
pressure
sensor
• The SmartMonitor has built-in humidity and atmospheric pressure sensors. The
sensors are located on the left side of the device and are covered by white
membrane/seal. Keep the membrane clean. Do not push, press, peel-off or pin
the white membrane as it will damage the sensors and affect the water
tightness.
Ingress
Protection • IP65: Protect from dust ingress and water spray from any direction.
Important: As the configuration can be changed in SmartView while the SmartMonitor
device is running and may not yet have been delivered to the device, the tick and the
cross on the device are indicative and may be revised when the configuration arrives
at the SmartMonitor.
!
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Liability
The manufacturer shall not be held liable.
• if the device was used beyond the manufacturer’s given limitations.
• for any claims due to the improper storage or use of the device.
• for any problems with the temperature-controlling and/or-cooling unit.
• for the quality of any monitored goods.
• for incorrect readings if the device was used beyond its expiry date.
Light sensor • Do not cover the light sensor with any label or tape to ensure functionality of
the light sensor.
Mechanical
force • Avoid violent shocks and impacts.
Microwave • Do not expose the device to microwave radiation (risk of battery explosion).
Multifunctional
button • Do not apply force as it will damage the button.
Recycling • Recycle the product at the end of its lifetime according to local regulations.
Safety
• Keep away from children.
• Don’t open it.
• Berlinger recommends training of all persons that handle the SmartMonitor
device and/or SmartView.
Sensor socket
(M5)
• The sensor socket (M5) is a sensitive part of the device.
• If you are not using the sensor socket (M5), keep it covered to protect from
water, dust, etc..
• When connecting a SmartSensor, take care to align the SmartSensor well with
the device to avoid damaging the pins of the sensor socket (M5).
• Do not apply force as it will damage the connector.
Temperature
• Temperatures outside the device operating temperature range may damage the
device and/or reduce its performance. To learn about the device operating
temperature range for each SmartMonitor type, see the information in the
technical specification.
X-rays/
Röntgen • Avoid long-term exposure to X-rays/Röntgen (risk of damaging the device).
Subject to change. Please note that all information in this document is correct at the time of publication.
Due to our policy of continuous product development, we reserve the right to change this information
without prior notice.
On the back of the device is a QR-code which links to a page, where more information about the device
is available. The information includes:
• User Manuals
• Quick Infos
• Technical Specifications
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If more help is needed, contact Berlinger support at [email protected].
Manufactured by:
Berlinger & Co. AG
Mitteldorfstrasse 2
9608 Ganterschwil
SWITZERLAND
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2.3. Device use
Ensure the SmartMonitor is securly installed and cannot fall.
The SmartMonitor can be fixed with:
• Velcro tape on the back of the SmartMonitor device
• Cable tie via the centered hook
• SmartCradle
Please note that all SmartMonitor SHIP devices are dedicated for shipment monitoring,
whereas the SmartMonitor SITE L is dedicated for site monitoring.
!
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2.4. Device cleaning
Important: The device shall not get in close contact with volatile chemicals such as
solvents or other organic compounds. Especially high concentration and long exposure
must be avoided. Ketenes, Acetone, Ethanol, Isopropyl Alcohol, Toluene, etc. are known
to cause drift of the humidity reading.
!
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2.5. Battery information & use
Battery shelf life:
Before first usage: Period from device delivery to customer (on stock), to first start of the device. Within
the battery shelf life periode, the device battery run time is ensured according to the technical
specification, if stored within the specified storage temperature (device off).
After first usage (in case of re-use): Period from device charge to start of the device.
If battery shelf life has been exceeded, the device cannot be started to avoid early depletion of the
battery during your shipment.
Battery
expiry
SmartMonitor SHIP M: once the battery shelf life has been exceeded, the battery expired. The
battery expiry date is printed on the front of the device.
If the battery is expired, the device cannot be started. The devices can be returned to Berlinger
for recycling and refurbishment.
Battery
recharge
SmartMonitor SHIP L/SITE L: once the battery shelf life has been exceeded, the battery expired
and the device needs to be recharged to ensure battery run time according to technical
specification.
Battery run time:
Time between start of the device until depletion of the battery without charging. Shipment devices cannot
be charged while monitoring.
Actual run time depends on environmental factors, such as temperature, quality of connectivity,
communication technologies and locations services used.
A comparison from the consumer environment:
Impact of temperature: if a mobile phone is exposed to very hot or very cold temperatures, it drains the
battery quickly. Berlinger therefore recommends the usage of a SmartSensor for minus temperature
ranges to ensure optimal battery run and device lifetime.
Impact of quality of connectivity: if a mobile phone is in an area of bad connectivity, where it continuously
is looking for a network, the battery is drained quickly.
Impact of communication technologies used: if a mobile phone is connecting to a 2G network, due to
unavailability of e.g., 4G network, the battery is drained quicker than with more efficient technologies
such as 4G, 5G.
Impact of location services: if the location service on a Smart watch is turned on, the battery of the watch
is drained much more quickly than if location is turned off.
Examples of battery shelf life and battery run time
Battery shelf life and battery run time of a SHIP L
The device start is within the battery shelf life:
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The device start is not within the battery shelf life:
If the device is not started within battery shelf life, recharge is required to ensure battery performance
according to technical specification.
Device cannot be started if battery shelf life has been exceeded, to avoid early depletion of the battery
during your shipment.
Battery shelf life and battery run time of a SITE L
The device start is within the battery shelf life:
The device start is not within the battery shelf life:
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If the device is not started within battery shelf life, recharge is required to ensure battery performance
according to technical specification.
Device cannot be started if battery shelf life has been exceeded, to avoid early depletion of the battery
during your shipment.
Battery shelf life and battery run time of a SHIP M
The device start is within the battery shelf life:
The device start is not within the battery shelf life:
If the device is not started within battery shelf life, the battery expired. The device can longer be started.
Devices can be returned to Berlinger for recycling and refurbishment.
Please find defined battery shelf life and battery run time per SmartMonitor device model in the technical
specification.
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2.6. Device lifetime
The typical device lifetime is defined based on a standard use case. Finally, the device lifetime depends
on number of usages, to which temperature ranges the device is exposed during its lifetime, careful
handling, amongst others.
Find the defined device lifetime per SmartMonitor device model in the technical specification.
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2.7. Air freight
In order to use SmartMonitor devices for product monitoring in air freight (device on), the SmartMonitor
device needs to be approved by the respective airline.
Before using the SmartMonitor on a shipment, please check the website of the respective airline or LINK
LANDING PAGE.
If the airline you would like to use, has not yet approved the SmartMonitor, please contact Berlinger at
[email protected].
Airlines may require the SmartMonitor or batteries to be declared on the AWB (Airway Bill).
For example:
SmartMonitor SHIP L Nickel metal hydride battery: Not restricted as per Special Provision A199.
SmartMonitor SHIP M Alkaline battery: Not restricted as per Special Provision A123.
Berlinger is not liable for approval to use the SmartMonitor on board of your selected carrier and the
correct declaration of the SmartMonitor.
Find the battery specifications per SmartMonitor device type in the technical specification.
Contact your airline for support of the correct declaration.
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2.8. Communication & Geographical
Positioning
•Communication
•Geographical Positioning
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